Immunovant will not pursue approval for the autoimmune medication

The latest Phase 3 trial results for Immunovant’s batoclimab drug showed achievement of the main study objective. Since it selected a new second-generation molecule instead of batoclimab for its product pipeline last year the company remains set against pursuing FDA approval for batoclimab treatment of myasthenia gravis or chronic inflammatory demyelinating polyneuropathy (CIDP).
The company chose IMVT-1402 as its main candidate over batoclimab last year. CEO Pete Salzmann told the audience at the J.P. Morgan Healthcare Conference in January that Immunovant’s development of batoclimab will likely not result in a commercial launch. The phase 3 myasthenia gravis results, together with phase 2b CIDP data, have not convinced Immunovant to change its commercialization plan.
In the batoclimab treatment trial, patients using low and high doses recorded 4.7- and 5.6-point better scores on the MG-ADL symptom and activity scale, respectively. Sirurus scores improved by 3.6 points within the placebo treatment group. The significant treatment difference between the research groups enabled the trial to reach its main endpoint goals.

Research data showed that Immunovant achieved IgG reduction rates of 64% and 74% which were measured against the low and high doses. The biotech organization evaluated its research through analysis of data from both Argenx’s Vyvgart and nipocalimab from Johnson & Johnson. The levels of IgG decrease and MG-ADL improvements associated with batoclimab at its low dose matched those measured in FcRn inhibitor products from Immunovant’s competitors.
Immunovant has chosen not to advance batoclimab for myasthenia gravis marketing despite its claim of exceeding therapeutic limits with the high dose. Data has shown batoclimab reduces albumin levels which resulted in cholesterol effects during testing. The biotech decided to display batoclimab clinical trial findings as their next-generation drug competition evidence despite moving forward with IMVT-1402.
This switch further cut Immunovant’s head start in the race, once it gave up to its competitors. In 2021, Vyvgart was FDA-approved and in 2023, was launched as a subcutaneous version. In myasthenia gravis, Immunovant has yet to begin a phase 3 trial of IMVT-1402.
After seeing phase 2b data on batoclimab in CIDP, the biotech confirms that the compound is its lead candidate in the disease. The molecule was connected to a reduction on CIDP scales in 84 percent of people with at least a 70 percent decrease in IgG, Immunovant said, meeting its response criteria. Like in myasthenia gravis, the biotech, however, has come to the same decision of moving forward with IMVT-1402 in the indication.

Batoclimab still has an open door to come up through in thyroid eye disease. The biotech will be verklempt when it sees phase 3 data and then look to make a final call on whether to file its first-generation FcRn inhibitor for approval in the space.